http://hl7.org/fhir/study-design|5.0.0
name
StudyDesign
StudyDesign
package
hl7.fhir.r5.core@5.0.0
hl7.fhir.r5.core@5.0.0
content
complete
complete
status
active
active
date
2020-12-28 05:55:11.0
2020-12-28 05:55:11.0
Study Design
This is a set of terms for study design characteristics.
| code | display | definition | hierarchy |
|---|---|---|---|
| SEVCO:01001 | Interventional research | A study design in which an independent variable (an exposure or intervention) is prospectively assig... | |
| SEVCO:01003 | randomized assignment | An interventional study design in which an independent variable (an exposure or intervention) is pro... | |
| SEVCO:01006 | simple randomization | A randomized assignment in which each participant has the same prespecified likelihood of being assi... | |
| SEVCO:01007 | stratified randomization | A randomized assignment in which participants are stratified into groups based on prognostic variabl... | |
| SEVCO:01008 | block randomization | A randomized assignment in which a pre-specified number of subjects is assigned to a block containin... | |
| SEVCO:01009 | adaptive randomization | A randomized assignment in which a participant’s group assignment probability is adjusted based on a... | |
| SEVCO:01005 | Non-randomized assignment | An interventional study design in which an independent variable (an exposure or intervention) is pro... | |
| SEVCO:01004 | Quasi-Randomized assignment | An interventional study design with a method of allocation that is not limited to random chance but ... | |
| SEVCO:01029 | Clinical trial | Interventional research in which one or more healthcare-related actions (i.e., a diagnostic, prognos... | |
| SEVCO:01041 | Pragmatic clinical trial | A clinical trial conducted under conditions of routine clinical practice.... | |
| SEVCO:01038 | Expanded Access study | A clinical trial that provides a means for obtaining an experimental drug or device for patients who... | |
| SEVCO:01030 | Phase 1 trial | A clinical trial to gather initial evidence in humans to support further investigation of an interve... | |
| SEVCO:01031 | Exploratory investigational new drug study | A clinical trial that is conducted early in phase 1, involves very limited human exposure, and has n... | |
| SEVCO:01032 | Phase 1/Phase 2 trial | A clinical trial with a component meeting the definition of phase 1 trial and a component meeting t... | |
| SEVCO:01033 | Phase 2 trial | A clinical trial to gather evidence of effectiveness and safety for an intervention in patients with... | |
| SEVCO:01034 | Phase 2/Phase 3 trial | A clinical trial with a component meeting the definition of phase 2 trial and a component meeting th... | |
| SEVCO:01035 | Phase 3 Trial | A clinical trial to gather the evidence of effectiveness and safety of an intervention, intended to ... | |
| SEVCO:01036 | Post-marketing study | A clinical trial to gather additional evidence of effectiveness and safety of an intervention for an... | |
| SEVCO:01002 | Observational research | A study design in which the independent variables (exposures or interventions) are not prospectively... | |
| SEVCO:01037 | Post-Marketing Surveillance study | An observational study to identify adverse events related to the use of an approved clinical interve... | |
| SEVCO:01010 | Comparative study design | A study design in which two or more groups are compared.... | |
| SEVCO:01011 | Parallel cohort design | A comparative study design in which the groups are compared concurrently and participants are expect... | |
| SEVCO:01012 | Crossover cohort design | A comparative study design in which participants receive two or more alternative exposures during se... | |
| SEVCO:01024 | Controlled crossover cohort design | A crossover cohort design in which two or more cohorts have different orders of exposures.... | |
| SEVCO:01025 | Single-arm crossover design | A crossover cohort design in which all participants are in a single cohort with the same order of ex... | |
| SEVCO:01013 | Case control design | A comparative study design in which the groups being compared are defined by outcome presence (case)... | |
| SEVCO:01014 | Matching for comparison | A comparative study design in which individual participants in different groups being compared are p... | |
| SEVCO:01020 | Family study design | A matched study design in which related or non-related family members are compared.... | |
| SEVCO:01021 | Twin study design | A family study design in which twin siblings are compared.... | |
| SEVCO:01015 | Cluster as unit of allocation | A comparative study design in which participants are allocated to exposures (interventions) by their... | |
| SEVCO:01023 | Non-comparative study design | A study design with no comparisons between groups with different exposures and no comparisons betwee... | |
| SEVCO:01016 | Uncontrolled cohort design | A non-comparative study design in which two or more participants are evaluated in a single group (or... | |
| SEVCO:01017 | Case report | A non-comparative study design in which a single participant is evaluated.... | |
| SEVCO:01022 | Population-based design | A study design in which the unit of observation is a population or community. ... | |
| SEVCO:01044 | Ecological design | A study design in which the unit of observation is a population or community defined by social relat... | |
| SEVCO:01027 | Cross sectional data collection | A study design process in which data is collected at a single point in time.... | |
| SEVCO:01028 | Longitudinal data collection | A study design process in which data is collected at two or more points in time.... | |
| SEVCO:01018 | Time series design | A longitudinal data collection which includes a set of time-ordered observations.... | |
| SEVCO:01019 | Before and after comparison | A time series design which includes comparisons of observations before and after an event or exposur... | |
| SEVCO:01045 | Primary data collection | A study design process in which the data are recorded and collected during the study for the purpose... | |
| SEVCO:01026 | Real world data collection | A study design process in which the study data are obtained from a source of data collected during a... | |
| SEVCO:01039 | Real world data collection from healthcare records | Real world data collection from data obtained routinely for a purpose of recording healthcare delive... | |
| SEVCO:01050 | Real world data collection from personal health records | Real world data collection from data obtained routinely for a purpose of recording data related to p... | |
| SEVCO:01040 | Real world data collection from healthcare financing records | Real world data collection from data obtained routinely for a purpose of recording healthcare financ... | |
| SEVCO:01048 | Real world data collection from testing procedures | Real world data collection from data obtained routinely for a purpose of testing, such as diagnostic... | |
| SEVCO:01046 | Real world data collection from monitoring procedures | Real world data collection from data obtained routinely for a purpose of repeated testing.... | |
| SEVCO:01049 | Secondary data collection from prior research | A study design process in which the data are collected from data obtained during a different study t... | |
| SEVCO:01042 | Secondary data collection from a registry | A study design process in which the data are collected from a system organized to obtain and maintai... | |
| SEVCO:01051 | Multisite data collection | A study design process in which data are collected from two or more geographic locations.... | |
| SEVCO:01086 | Quantitative analysis | A study design process in which data are analyzed with mathematical or statistical methods and formu... | |
| SEVCO:01087 | Qualitative analysis | A study design process in which data are analyzed, without primary reliance on mathematical or stati... | |
| SEVCO:01060 | Blinding of study participants | A study design process in which study participants are not informed of their intervention assignment... | |
| SEVCO:01061 | Blinding of intervention providers | A study design process in which the people administering the intervention are not informed of the in... | |
| SEVCO:01062 | Blinding of outcome assessors | A study design process in which the people determining the outcome are not informed of the intervent... | |
| SEVCO:01063 | Blinding of data analysts | A study design process in which the people managing or processing the data and statistical analysis ... | |
| SEVCO:01064 | Allocation concealment | A study design process in which all parties influencing study enrollment and allocation to study gro... | |
| SEVCO:01043 | Multicentric | A study design feature in which two or more institutions are responsible for the conduct of the stud... | |
| SEVCO:01052 | Includes patient-reported outcome | A study design feature in which one or more outcomes are reported directly from the patient without ... | |
| SEVCO:01053 | Includes patient-centered outcome | A study design feature in which one or more measures are outcomes that patients directly care about,... | |
| SEVCO:01054 | Includes disease-oriented outcome | A study design feature in which one or more measures are outcomes that relate to a health or illness... | |
| SEVCO:01085 | Includes process measure | A study design feature in which one or more outcomes are actions or behaviors of a healthcare profes... | |
| SEVCO:01089 | Study Goal | A study design feature specifying the intent of the study.... | |
| SEVCO:01096 | Evaluation Goal | A study goal to assess the efficiency, effectiveness, and impact of a given program, process, person... | |
| SEVCO:01097 | Derivation Goal | A study goal with the intent to generate a predictive algorithm.... | |
| SEVCO:01098 | Validation Goal | A study goal with the intent to determine the reliability and/or performance of a procedure for a sp... | |
| SEVCO:01088 | Comparison Goal | A study design feature in which the study intent is to compare two or more interventions or exposure... | |
| SEVCO:01091 | Comparative Effectiveness Goal | A study design feature in which the study intent is to compare two or more interventions with respec... | |
| SEVCO:01090 | Comparative Efficacy Goal | A study design feature in which the study intent is to compare two or more interventions with respec... | |
| SEVCO:01092 | Comparative Safety Goal | A study design feature in which the study intent is to compare two or more interventions with respec... | |
| SEVCO:01093 | Equivalence Goal | A study goal with the intent to compare two or more interventions or exposures and determine that an... | |
| SEVCO:01094 | Non-inferiority Goal | A study goal with the intent to compare two or more interventions or exposures and determine that an... | |
| SEVCO:01095 | Superiority Goal | A study goal with the intent to compare two or more interventions or exposures and detect a differen... |